NovaBridge Biosciences Scores FDA Fast Track for Givastomig in Metastatic Gastric Cancer
NBP•NovaBridge Biosciences won FDA Fast Track Designation for its givastomig bispecific antibody combined with nivolumab and chemotherapy in first-line HER2-negative metastatic gastric cancer. Registrational Phase 3 is slated to start Q4 2026 with detailed Phase 1b data due at a major medical conference in H2 2026.
1. FDA Fast Track Designation
NovaBridge has obtained Fast Track designation from the FDA for its lead candidate givastomig combined with nivolumab and chemotherapy in first-line HER2-negative metastatic gastric cancer. The designation accelerates development and review, potentially enabling rolling submissions, priority review and accelerated approval pathways.
2. Phase 1b Data Highlights
Phase 1b data showed robust efficacy and tolerability of givastomig in CLDN18.2 and PD-L1 positive gastroesophageal adenocarcinoma patients, with deep, durable responses surpassing historical benchmarks for standard immunochemotherapy regimens.
3. Phase 3 Trial Timeline
The registrational Phase 3 trial is planned to commence in Q4 2026, with detailed Phase 1b results scheduled for presentation at a major medical conference in H2 2026, positioning NovaBridge for accelerated clinical milestones.
4. Broader Pipeline Context
Givastomig is the flagship asset in a pipeline that also includes VIS-101 for retinal vascular diseases and uliledlimab for immunosuppression in cancer, highlighting NovaBridge’s strategy of advancing first-in-class and best-in-class bispecific antibodies globally.
